A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

Trial Details

NCT ID
NCT05848739
Phase
PHASE1
Sponsor
Sapience Therapeutics
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • ST316
  • FOLFIRI regimen & bevacizumab
  • Fruquintinib
  • Lonsurf & bevacizumab
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Los Angeles, California, United States|34.05223,-118.24368
  • Denver, Colorado, United States|39.73915,-104.9847
  • New Orleans, Louisiana, United States|29.95465,-90.07507
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Able and willing to sign an informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.
  • Male or female ≥18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Must have a locally advanced or metastatic inoperable tumor as follows:

For full eligibility, visit ClinicalTrials.gov.

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